A phase 1 study establishing the safety of intrapleural administration of liposomal curcumin (LipoCurc) as a palliative treatment for malignant pleural effusion

Flinders University0 sites9 target enrollmentNovember 16, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 16, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Adults aged 18 years or older with an existing diagnosis of malignant pleural effusion on pleural biopsy or pleural fluid cytology in line with established standard practice for the diagnosis of malignant pleural effusion.
•2\. Individuals who have failed to respond to approved systemic therapies (chemotherapy, immune therapy or molecular targeted therapies), or who have progressive cancers following initial response to these therapies, and for whom no anti\-tumour therapy of proven benefit is available at study enrolment.
•3\. People who have declined systemic therapies or are deemed not suitable for systemic therapies after consultation with a medical oncologist.
•4\. Recurrent symptomatic pleural effusion where insertion of a TIPC is clinically indicated.
•5\. Eastern Co\-operative Performance Status 0 \- 2\.
•6\. Able to give signed informed consent.
•4\. People whose primary language is English.

•1\. Women who are pregnant and/or breastfeeding, and/or of childbearing age not taking contraceptive measures to avoid pregnancy while participating in the study.
•2\. People under 18 years of age.
•3\. People with mental impairment, or an unstable medical condition other than cancer, that may interfere with their ability to provide informed consent or ability to cooperate and participate in the study.
•4\. People with evidence of active hepatitis.
•5\. People with a diagnosis of lymphoma or a haematological cancer.
•6\. People with a history of haemolytic anaemia.
•7\. People with unresolved toxicities from prior systemic anti\-cancer therapy.
•8\. People with an unstable cardiac condition as determined by the study investigator.